| CTRI Number |
CTRI/2025/12/099831 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
This study checks whether using elastic like tape applied on the front leg and the back of leg from ankle to knee on affected side can immediately improve the way they place foot on ground while they walk and analyse walking in people who had a paralysis more than 6 months. |
|
Scientific Title of Study
|
Immediate Effect of Kinesiotaping on Tibialis Anterior
and Gastrosoleus on Gait in Chronic Stroke
Patients: A Randomised Crossover Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahima Pathawar |
| Designation |
Postgraduate Student |
| Affiliation |
TMV s Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, third floor, department of Neurophysiotherapy, Tilak Maharashtra Vidyapeeth, J block, Sector 14, Near raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9920514909 |
| Fax |
|
| Email |
mahimapathawar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranjal Grover |
| Designation |
Principal and professor |
| Affiliation |
TMV s Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, third floor, department of Neurophysiotherapy, Tilak Maharashtra Vidyapeeth, J block, Sector 14, Near raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9619064917 |
| Fax |
|
| Email |
drpranjal.grover@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranjal Grover |
| Designation |
Principal and professor |
| Affiliation |
TMV s Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, third floor, department of Neurophysiotherapy, Tilak Maharashtra Vidyapeeth, J block, Sector 14, Near raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9619064917 |
| Fax |
|
| Email |
drpranjal.grover@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMVs Lokmanya Tilak College of Physiotherapy, Third floor, Department of of Neurophysiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai-410210, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
Third floor, department of Neurophysiotherapy, Tilak Maharashtra Vidyapeeth, J block, Sector 14, Near raghunath Vihar, Kharghar, Navi Mumbai-410210, Maharashtra, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy, third floor, department of Neurophysiotherapy, Tilak Maharashtra Vidyapeeth, J block, Sector 14, Near raghunath Vihar, Kharghar, Navi Mumbai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahima Pathawar |
TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy, third floor, department of Neurophysiotherapy, Tilak Maharashtra Vidyapeeth, J block, Sector 14, Near raghunath Vihar, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA |
9920514909
mahimapathawar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMVs Lokmanya Tilak College of Physiotherapy Institutional Ethics Comitte |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesiology Taping and conventional Therapy |
Elastic tape will be applied to the affected leg over both the anterior and posterior muscle groups with stretch applied to facilitate or inhibit muscle activity as required. Conventional exercises will be administered concurrently, and the outcomes will be analyzed subsequently.Its a pre Post study so total duration of intervention is 1 hour |
| Comparator Agent |
Sham Taping and conventional therapy |
Elastic tape will be applied to the affected leg over both the anterior and posterior muscle groups without stretch . Conventional exercises will be administered concurrently, and the outcomes will be analyzed subsequently. Its a pre Post study so total duration of intervention is 1 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Stroke Onset: At least 6 months post-stroke.and
willing to participate in the study
Walking Ability Walk 10 meters or more with or
without assistance
Cognitive Function MMSE score more than equal to 24.
Modified Ashworth Scale more than equal to 2 |
|
| ExclusionCriteria |
| Details |
Cognitive, visual Cardiorespiratory disorder
(including cardiac pacemaker placement, heart
failure, and arrhythmia)
Orthopedic intervention due to an ankle problem
Balance disorder with dizziness
Plantarflexion Contracture
Skin disease, open wounds
Botulinum toxin injections within the prior year
Other Neurological disorders |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kinovea Software
|
Time point is at baseline and 1 hour post intervention for sham taping followed by 7 days of washout period and Kinesiotaping having timeline at baseline and 1 hour post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wisconsin Gait Scale |
Time point is at baseline & 1 hour post intervention for sham taping followed by 7 days of washout period & Kinesiotaping having timeline at baseline & 1 hour post intervention |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Written informed consent will be taken from all participants before the study begins. Baseline gait assessment will be performed after removing footwear and any ankle–foot orthosis. Gait will be recorded using a mobile phone and analyzed with Kinovea software, and clinical gait performance will be assessed using the Wisconsin Gait Scale.
Participants will first receive sham taping to the tibialis anterior and gastrosoleus muscles, applied without stretch. An immediate post-taping gait assessment will then be carried out using the same outcome measures. After a one-week washout period, participants will undergo a second baseline assessment. Kinesiotaping will then be applied by a trained physiotherapist with 25–50% stretch following standard taping techniques. A final immediate post-taping gait assessment will be performed. All taping applications and assessments will be done by the same therapist to maintain consistency. |